Community engagement in tuberculosis research: the EU-Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) experience
Objectives: Community representatives are key to ensuring that tuberculosis (TB) research is relevant, culturally sensitive, and appropriate. For all trials (new drugs or treatment regimens, diagnostics, or vaccines) this can result in improvement of recruitment, retention, and adherence to the tria...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-05-01
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| Series: | International Journal of Infectious Diseases |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1201971223000851 |
| _version_ | 1797813785020334080 |
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| author | Francesca Saluzzo Juan Espinosa-Pereiro Stephan Dressler Ezio Tàvora Dos Santos Filho Stephanie Seidel Jesus Gonzalez Moreno Norbert Heinrich Adrian Sanchez-Montalva Daniela Maria Cirillo |
| author_facet | Francesca Saluzzo Juan Espinosa-Pereiro Stephan Dressler Ezio Tàvora Dos Santos Filho Stephanie Seidel Jesus Gonzalez Moreno Norbert Heinrich Adrian Sanchez-Montalva Daniela Maria Cirillo |
| author_sort | Francesca Saluzzo |
| collection | DOAJ |
| description | Objectives: Community representatives are key to ensuring that tuberculosis (TB) research is relevant, culturally sensitive, and appropriate. For all trials (new drugs or treatment regimens, diagnostics, or vaccines) this can result in improvement of recruitment, retention, and adherence to the trial schedule. The early engagement of the community will, later in time, support the process of implementation of new policies designed for successful products. We aim at developing a structured protocol for the early engagement of TB community representatives developed in the context of the EU-Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) project. Design: The EU-PEARL Innovative Medicine Initiative 2 (IMI2) project TB work package has developed a community engagement (CE) framework to ensure fair and efficient participation of the community in the design and implementation of TB clinical platform trials. Results: We showed that early engagement of the EU-PEARL community advisory board highly contributes to the process of development of a community-acceptable Master Protocol Trial and Intervention-Specific Appendixes. We identified capacity building and training as major gaps in advancing CE in the TB field. Conclusion: Developing strategies to address these needs can contribute to preventing tokenism and increase the acceptability and appropriateness of TB research. |
| first_indexed | 2024-03-13T07:56:54Z |
| format | Article |
| id | doaj.art-396bef58134d43ebbfe193062c6e61c8 |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-03-13T07:56:54Z |
| publishDate | 2023-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-396bef58134d43ebbfe193062c6e61c82023-06-02T04:22:42ZengElsevierInternational Journal of Infectious Diseases1201-97122023-05-01130S20S24Community engagement in tuberculosis research: the EU-Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) experienceFrancesca Saluzzo0Juan Espinosa-Pereiro1Stephan Dressler2Ezio Tàvora Dos Santos Filho3Stephanie Seidel4Jesus Gonzalez Moreno5Norbert Heinrich6Adrian Sanchez-Montalva7Daniela Maria Cirillo8Vita-Salute San Raffaele University, Milan, Italy; Division of Immunology, Transplantation & Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, ItalyInfectious Diseases Department, Vall d'Hebrón University Hospital, Global Health Program from the Catalan Health Institute (PROSICS), Universitat Autònoma de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, SpainEU-PEARL: EU Patient-cEntric clinicAl tRial pLatforms, WP5 – Integrated Research Platform for Tuberculosis (TB) Community Advisory Group, Berlin, GermanyEU-PEARL: EU Patient-cEntric clinicAl tRial pLatforms, WP5 – Integrated Research Platform for Tuberculosis (TB) Community Advisory Group, Rio De Janeiro, BrazilCommunity Engagement and Stakeholder Relations, Global Alliance for TB Drug Development, New York, USAJanssen-Cilag S.A. Spain, Part of Janssen Pharmaceutical Companies, Madrid, SpainDivision of Infectious Diseases and Tropical Medicine, University Hospital, LMU, Munich, GermanyInfectious Diseases Department, Vall d'Hebrón University Hospital, Global Health Program from the Catalan Health Institute (PROSICS), Universitat Autònoma de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas (CIBERINFEC), Instituto de Salud Carlos III, Madrid, Spain; Mycobacterial Infection Study Group from the Spanish Society of Clinical Microbiology and Infectious Diseases (GEIM-SEIMC), Barcelona, SpainVita-Salute San Raffaele University, Milan, Italy; Division of Immunology, Transplantation & Infectious Diseases, IRCCS San Raffaele Scientific Institute, Milan, Italy; Corresponding author.Objectives: Community representatives are key to ensuring that tuberculosis (TB) research is relevant, culturally sensitive, and appropriate. For all trials (new drugs or treatment regimens, diagnostics, or vaccines) this can result in improvement of recruitment, retention, and adherence to the trial schedule. The early engagement of the community will, later in time, support the process of implementation of new policies designed for successful products. We aim at developing a structured protocol for the early engagement of TB community representatives developed in the context of the EU-Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) project. Design: The EU-PEARL Innovative Medicine Initiative 2 (IMI2) project TB work package has developed a community engagement (CE) framework to ensure fair and efficient participation of the community in the design and implementation of TB clinical platform trials. Results: We showed that early engagement of the EU-PEARL community advisory board highly contributes to the process of development of a community-acceptable Master Protocol Trial and Intervention-Specific Appendixes. We identified capacity building and training as major gaps in advancing CE in the TB field. Conclusion: Developing strategies to address these needs can contribute to preventing tokenism and increase the acceptability and appropriateness of TB research.http://www.sciencedirect.com/science/article/pii/S1201971223000851Community engagementTuberculosis researchClinical trials |
| spellingShingle | Francesca Saluzzo Juan Espinosa-Pereiro Stephan Dressler Ezio Tàvora Dos Santos Filho Stephanie Seidel Jesus Gonzalez Moreno Norbert Heinrich Adrian Sanchez-Montalva Daniela Maria Cirillo Community engagement in tuberculosis research: the EU-Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) experience International Journal of Infectious Diseases Community engagement Tuberculosis research Clinical trials |
| title | Community engagement in tuberculosis research: the EU-Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) experience |
| title_full | Community engagement in tuberculosis research: the EU-Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) experience |
| title_fullStr | Community engagement in tuberculosis research: the EU-Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) experience |
| title_full_unstemmed | Community engagement in tuberculosis research: the EU-Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) experience |
| title_short | Community engagement in tuberculosis research: the EU-Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) experience |
| title_sort | community engagement in tuberculosis research the eu patient centric clinical trial platforms eu pearl experience |
| topic | Community engagement Tuberculosis research Clinical trials |
| url | http://www.sciencedirect.com/science/article/pii/S1201971223000851 |
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